<?xml version="1.0" encoding="UTF-8"?><lom xmlns="http://ltsc.ieee.org/xsd/LOM" xmlns:lomfr="http://www.lom-fr.fr/xsd/LOMFR" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xsi:schemaLocation="http://ltsc.ieee.org/xsd/LOM http://www.lom-fr.fr/xsd/lomfrv1.0/std/lomfr.xsd">
<general>
<identifier>
<catalog>Canal-U_Ocms</catalog>
<entry>10914</entry>
</identifier>
<title><string language="fre"><![CDATA[Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 : debate : Best statistical methods for evaluating the merits of a novel marker (debates).]]></string></title>
<language>ENG</language>
<description>
<string language="fre"><![CDATA[Title : Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 : debate : Best statistical methods for evaluating the merits of a novel marker (debates).
Speaker: Stefan BLANKENBERG, Hamburg, GER
Discussant: Nancy GELLER, Bethesda, USA
Abstract : debate : Best statistical methods for evaluating the merits of a novel marker (debates).
The measurement of biomarkers for diagnosis and prognosis in heart disease has changed the fundamental way that patients are evaluated, and has led to a literal explosion of studies exploring both novel applications of established biomarkers as well as the discovery of newer biological markers. With the rise in interest in novel biomarkers has come a clear heterogeneity in the approach with which these potentially important tests have been studied, partially due to a lack of guidance as to nominal expectations for the approach for their evaluation. To this point, there is no consensus yet articulated with respect to the minimum expectations for which a new diagnostic or prognostic biomarker should be held to in order to clarify or reject their potential value. We recently proposed several standards to which novel biomarkers in heart failure should be held during their evaluation (Table) (1); these “rules” do not specifically apply to heart failure per se, and could thus theoretically serve as a starting point for determining the basic framework upon which the evaluation of novel applications of prior markers or the description of a frankly new biomarker.
1. The method by which a novel biomarker is judged (including and especially when compared to or in combination with other biomarkers) should be thorough: novel tests should be evaluated across a wide range of patients typical of the diagnosis for which it will be applied, and the statistical methods used to evaluate the biomarker (relative to clinical variables as well as other biomarkers) should be contemporary, rigorous, standardized and fair.
2. Measurement of a novel HF biomarker (e.g. in blood, urine or any easy obtainable tissue) should be easily achieved within a short period of time, provide acceptable accuracy and assays for its measurement should have defined biological variation and low analytical imprecision.
3. The biomarker should primarily reflect important (patho) physiological process(es) involved in HF presence and progression; use of biomarkers reflective of disease but originating outside the myocardium is acceptable as long as such a biomarker provides independently useful information involved in the diagnosis, prognosis, progression or therapy of HF syndromes.
4. The biomarker must provide clinically useful information for caregivers (physician, nurses, patient and others) to more swiftly and reliably establish/reject a diagnosis, to more accurately estimate prognosis, or to inform more successful therapeutic strategies. The information from such a biomarker should not recapitulate clinical information already available at the bedside, and must be additional to other biomarkers.
L’auteur n’a pas transmis de conflit d’intérêt concernant les données diffusées dans cette vidéo ou publiées dans la référence citée.
9th Global Cardiovascular Clinical Trialists Forum • Paris 2012 
WHAT IS THE OPTIMAL DESIGN FOR BIOMARKER STUDIES?
Chairpersons: Jim JANUZZI, Boston, USA - Faiez ZANNAD, Nancy, FRA
Réalisation, production : Canal U/3S et CERIMES
Keyword : Cardiovascular Clinical Trialists, Paris, 2012, Cardiovascular prevention, cardiovascular pharmacology, biomarker]]></string></description>
<keyword><string language="fre"><![CDATA[Cardiovascular Clinical Trialists, Paris, 2012, Cardiovascular prevention, cardiovascular pharmacology, biomarker]]></string></keyword>
<lomfr:documentType>
<lomfr:source>LOMFRv1.0</lomfr:source>
<lomfr:value>image en mouvement</lomfr:value>
</lomfr:documentType>
</general><lifeCycle>
<contribute>
<role>
<source>LOMv1.0</source>
<value>author</value>
</role>
<entity><![CDATA[BEGIN:VCARD
VERSION:3.0
CLASS:PUBLIC
REV:2021-07-06 15:37:26
FN:Stefan BLANKENBERG
N:BLANKENBERG;Stefan;;;
URL;TYPE=work:https://www.canal-u.tv/auteurs/blankenberg_stefan
ROLE:author
NOTE:Stefan BLANKENBERG, Hamburg, GER 
TZ:+0200
END:VCARD
]]></entity>
<date><dateTime>2012-12-01</dateTime></date>
</contribute>
<contribute>
<role>
<source>LOMv1.0</source>
<value>author</value>
</role>
<entity><![CDATA[BEGIN:VCARD
VERSION:3.0
CLASS:PUBLIC
REV:2021-07-06 15:37:26
FN:Nancy GELLER
N:GELLER;Nancy;;;
URL;TYPE=work:https://www.canal-u.tv/auteurs/geller_nancy
ROLE:author
NOTE:GELLER Nancy, NHLBI, USA&lt;br&gt;Nancy L. Geller has been the Director of the Office of Biostatistics Research at the National Heart, Lung and Blood Institute of the National Institutes of Health since 1990. She directs a group of 12 statisticians who collaborate in the design, implementation, monitoring and analysis of multicenter clinical trials in heart, lung and blood diseases and sleep disorders and administers all statistical activities of the National Heart, Lung and Blood Institute. She has been or is involved in the design and analysis of a number of cardiovascular trials, including PEACE, AFFIRM, WHI (Women’s Health Initiative), FREEDOM, ACCORD, COAG (Clarification of Optimal Anticoagulation through Genetics) and the Ranolazine ICD trial (RAID). She has published nearly 200 papers in the statistical and medical literature. She is an Associate Editor of Biometrics and a member of the Editorial Board of Clinical Trials. She is a Fellow of both the International Statistics Institute and the American Statistical Association. She was the winner of the 2009 Janet L. Norwood Award for outstanding achievement by a woman in the statistical sciences and was 2011 President of the American Statistical Association. 
TZ:+0200
END:VCARD
]]></entity>
<date><dateTime>2012-12-01</dateTime></date>
</contribute>
</lifeCycle>
<metaMetadata>
<metadataSchema>LOMv1.0</metadataSchema>
<metadataSchema>LOMFRv1.0</metadataSchema>
</metaMetadata>
<technical>
<format>video/mp4</format>
<location><![CDATA[https://www.canal-u.tv/video/canal_u_medecine/cardiovascular_clinical_trialists_cvct_forum_paris_2012_debate_best_statistical_methods_for_evaluating_the_merits_of_a_novel_marker_debates.10914]]></location>
<location><![CDATA[https://streaming-canal-u.fmsh.fr/vod/media/canalu/videos/cutms/cardiovascular.clinical.trialists.cvct.forum.a.paris.2012.debate.best.statistical.methods.for.evaluating.the.merits.of.a.novel.marker.debates._10914/2.22.cvct2012_debats_sd.mp4]]></location>
<location><![CDATA[https://streaming-canal-u.fmsh.fr/vod/media/canalu/videos/cutms/cardiovascular.clinical.trialists.cvct.forum.a.paris.2012.debate.best.statistical.methods.for.evaluating.the.merits.of.a.novel.marker.debates._10914/2.22.cvct2012_debats_bd.mp4]]></location>
<size>51197100</size>
<duration><duration>PT0H10M1S</duration></duration>
</technical>
<educational>
<learningResourceType>
<source>LOMv1.0</source>
<value>lecture</value>
</learningResourceType>
<context>
<source>LOMv1.0</source>
<value>higher education</value>
</context>
<context>
<source>LOMv1.0</source>
<value>formation continue</value>
</context>
</educational>
<rights>
<cost>
<source>LOMv1.0</source>
<value>no</value>
</cost>
<copyrightAndOtherRestrictions>
<source>LOMv1.0</source>
<value>no</value>
</copyrightAndOtherRestrictions>
<description>
<string language="fre"><![CDATA[Droits réservés à l'éditeur et aux auteurs. 
]]></string>
</description>
</rights>
<relation>
<kind>
<source>LOMv1.0</source>
<value>ispartof</value>
</kind>
<resource>
<identifier>
<catalog>URI</catalog>
<entry>https://www.canal-u.tv/producteurs/canal_u_medecine/cardiologie/colloque_et_evenement/cvct</entry>
</identifier>
<description>
<string language="fre"><![CDATA[CVCT 9th Global Cardiovascular Clinical Trialists Forum • Paris 2012]]></string>
</description>
</resource>
</relation>
<classification>
<purpose>
<source>LOMv1.0</source>
<value>discipline</value>
</purpose>
<taxonPath>
<source>
<string language="fre"><![CDATA[Universités Numériques Thématiques 2009 http://www.universites-numeriques.fr]]></string>
</source>
<taxon>
<id/>
<entry>
<string language="fre"/>
</entry>
</taxon>
</taxonPath>
</classification>
<classification>
<purpose>
<source>LOMv1.0</source>
<value>discipline</value>
</purpose>
<taxonPath>
<source>
<string language="fre">CDD 22e éd.</string>
<string language="eng">DDC 22nd ed.</string>
</source>
<taxon>
<id>610</id>
<entry>
<string language="fre"><![CDATA[Sciences médicales. Médecine]]></string>
</entry>
</taxon>
</taxonPath>
</classification> </lom>